Actoplus Met XR and Pregnancy
In animal studies, large doses of Actoplus Met XR (pioglitazone and metformin XR) caused an increased risk of miscarriages and delayed fetal growth when given to rats. However, animals and humans can respond to the same drug in different ways. Therefore, a woman who is pregnant may take Actoplus Met XR if her healthcare provider believes that the benefits outweigh the risks.
Can Pregnant Women Take Actoplus Met XR?Actoplus Met® XR (pioglitazone and metformin XR) may not be safe for pregnant women, due to the pioglitazone component of the drug. This is based on animal studies that looked at the effects of Actoplus Met XR during pregnancy.
What Is Pregnancy Category C?The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but that did appear to cause harm to the fetus in animal studies.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Actoplus Met XR is a combination of two different diabetes medications: pioglitazone hydrochloride (Actos®) and metformin hydrochloride (Fortamet®, Glucophage®, Glucophage XR®, Glumetza®, or Riomet®).
In animal studies, giving large doses of pioglitazone to pregnant rats increased the risk of miscarriages and slowed down the growth of the fetal rats. It is important to note, however, that animals do not always respond to medicines in the same way that humans do.
Therefore, a pregnancy Category C drug may be given to a pregnant woman if the healthcare provider believes that the benefits to the mother outweigh any possible risks to the unborn child.
The metformin component of Actoplus Met XR poses less of a risk, as it is often used during pregnancy (see Metformin and Pregnancy).